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Found 10 results
510(k) Data Aggregation
K Number
K132195Device Name
EUROIMMUN ANTI-PLA2R ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2014-06-27
(347 days)
Product Code
PGV
Regulation Number
866.5780Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN Anti-PLA2R ELISA (IgG) consists of a microwell ELISA plate coated with PLA2R antigen, 5 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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K Number
K100017Device Name
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
Manufacturer
EUROIMMUN US INC
Date Cleared
2010-09-13
(252 days)
Product Code
OSK
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN IFA is an assay for standardized detection of anti-glutamate receptor (type NMDA) antibodies utilized in each laboratories familiar with indirect immunofluorescence. The non-transfected cells are used as a control to simplify differentiation of potential co-existing and non-specific reactivity such as ANA. The test kit consists of slides, which contain BIOCHIPs coated with glutamate receptor (type NMDA) transfected cells and non-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for transforced volle and non new and of a negative control, a salt for preparation of PBS, Tween 20, embedding medium, cover glasses and an instruction booklet.
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K Number
K091969Device Name
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2010-09-02
(428 days)
Product Code
NBO
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K092736Device Name
EUROIMMUN ANTI-M2-3E ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2010-09-02
(363 days)
Product Code
DBM
Regulation Number
866.5090Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-M2-3E ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against the mitochondrial antigens M2 in human serum and plasma. It is used as an aid in the diagnosis of primary billary cirrhosis (PBC), in conjunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN Anti-M2-3E ELISA (IgG) consists of a microwell ELISA plate coated with M2-3E antigen, 3 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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K Number
K083053Device Name
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-08-07
(297 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K083052Device Name
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-07-28
(287 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
Device Description
Not Found
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K Number
K083850Device Name
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-05-20
(147 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K083381Device Name
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-04-15
(152 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K082130Device Name
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-04-07
(252 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K083615Device Name
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-03-16
(98 days)
Product Code
OEG
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EUROIMMUN US INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.
Device Description
Not Found
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